Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT01009034)

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The objective of this study is to determine if concentrations of maraviroc in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extent of maraviroc penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of maraviroc in semen, and to determine the variability in the penetration of maraviroc into the seminal compartment over the maraviroc dosing period.

Condition or disease

Intervention/treatment

Maraviroc Concentrations in Semen

Other: Measuring semen samples

Detailed Description:

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load < 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.

Other: Measuring semen samples

Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.

Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. [ Time Frame: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample. ]

We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.

Secondary Outcome Measures
:

Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval [ Time Frame: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample ]

For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.

Determine the Area Under the Concentration Time Curve of Maraviroc in Semen. [ Time Frame: 6 months ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

12 HIV-positive males

Criteria

Inclusion Criteria:

HIV infected male

18 years old or older

on maraviroc twice daily as part of their antiretroviral regimen for at least 3 months prior to screening

viral load < 50 copies/mL at least one month prior to enrolling

able to read, understand and sign a written informed consent prior to initiation of the study

medically stable at the time of the study, with no evidence of acute illness

Exclusion Criteria:

having difficulty adhering to current antiretroviral therapy

patient is expected to have difficulties adhering with study protocol

patients with malignancy, or acute renal or liver disease

patient with active AIDS-defining illness

patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent

patient with any of the following abnormalities at the time of screening:

hemoglobin < 85 g/L

absolute neutrophil count < 1000 cells/uL

platelet count < 50,000 cells/uL

AST, ALT or total bilirubin > 3 times the upper limit of normal

serum creatinine > 1.5 times upper limit of normal

patient receiving concomitant therapy with rifampin or St. John's wort